BEUDAMED
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    ABUSCREEN ONTRAK FOR BENZODIAZEPINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665583178·MIS Cannulated Screw, Ø10.5 x 90mm, Ø5.5mm Rod

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756356749·LUMBAR DISC PACK

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112304·SURG-I-BAND BROWN

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450210376·

    NEUROPACK MICRO, MODEL MED-9100A SERIES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INTRABEAM NEEDLE APPLICATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 11, 2013

    INNERVISION SNAP SHUNT VENT CATHETER, BG, 6CM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·November 19, 2010

    SECUR-FIT MAX 127 #11

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·July 2, 2014

    BIOMET CC CRUCIATE TRAY 87MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 28, 2021

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021